NIH Grant Writing Tips Kelli A Komro MPH

NIH Grant Writing Tips Kelli A. Komro, MPH, Ph. D Associate Professor, Department of Epidemiology and Health Policy Research, COM Associate Director, Institute for Child Health Policy www. ehpr. ufl. edu www. ichp. ufl. edu komro@ufl. edu

Outline • • • My background NIH structure and budget Types of awards Peer review process Grant writing tips UF NIH investigators & grant writing course – CRISP: http: //crisp. cit. nih. gov/ – ICHP: www. ichp. ufl. edu

Research Background Research Experience • Ph. D in Epidemiology, 1994, University of Minnesota • Associate Professor, EHPR and Associate Director, ICHP • $29 M in grant funding, mostly NIH • Child & adolescent health; community-wide preventive interventions; group-randomized trials • Mentor graduate students and junior faculty Grant Review Experience • NIH grant reviews • UK’s Medical Research Council

Goal: To adapt, implement and evaluate an alcohol preventive intervention for urban young adolescents

U. S. Department of Health and Human Services The Secretary Deputy Secretary Administration for Children and Families (ACF) Administration on Aging (Ao. A) Food and Drug Administration (FDA) Centers for Medicare and Medicaid Services (CMS) Agency for Health Care Policy and Research (AHCPR) Indian Health Services (IHS) Centers for Disease Control and Prevention (CDC) Agency for Toxic Substances and Disease Registry (ATSDR) Substance Abuse and Mental Health Services Administration (SAMHSA) Health Resources and Services Administration (HRSA) National Institutes of Health (NIH) Program Support Center (PSC)

National Institutes of Health Mission NIH conducts and supports basic, applied, clinical and health services research to understand the processes underlying human health and to acquire new knowledge to help prevent, diagnose, and treat human diseases and disabilities.

NIH Funding • Increase in applications & applicants • Flat budget & inflation • Success rates per application – 2008: 19% – 1999: 27% • Strategies to encourage and support junior scientists – 2009 payline: 25%

National Institutes of Health Officeof ofthe the. Director National. Institute on on. Aging National. Institute on on. Alcohol. Abuse and. Alcoholism National. Institute of of. Allergyand Infectious. Diseases National. Institute of of. Arthritisand Musculoskeletal and and. Skin. Diseases National. Cancer Institute National. Institute of of. Child. Health and. Human Development National. Instituteon on Deafnessand and. Other Communication Disorders National. Institute of of. Dentaland Craniofacial Research National. Institute of of. Diabetesand Digestiveand Kidney. Diseases National. Institute on on. Drug. Abuse National. Institute of of. Environmental Health. Sciences National. Eye Institute National. Institute of of. General Medical. Sciences National. Heart, Lung, and. Blood Institute National. Human Genome. Research Institute National. Institute of of. Mental. Health National. Institute of of. Neurological Disordersand Stroke National. Institute of of. Nursing. Research National. Instituteof of Biomedical. Imaging and. Bioengineering National. Center for. Complementary and. Alternative Medicine National. Center for. Research Resources National. Library of of. Medicine National. Centeron on Minority Healthand Health. Disparities Fogarty International Center Clinical. Centerfor Information Technology Centerfor Scientific. Review

Institute/Center Program Officers • A scientist and administrator • Manages grants, contracts, cooperative agreements • Identifies needs in scientific areas • Identifies scientific areas of special interest and communicates interest • Monitors research progress • Advocates for the best science

Institute/Center Strategic Plans • Institute/Center web sites • Strategic plans – http: //report. nih. gov/strategicplans/index. aspx • • Priority areas Program Announcements (PAs) Request for Applications (RFAs) American Recovery and Reinvestment Act – $10. 4 B in support of scientific research priorities, available for two years

National Institute for Child Health and Human Development ARRA Priorities • GO Grants, due May 27, 2009 – – Developmental Biology and Perinatal Medicine Maternal and Child Health Contraception, Reproduction and Population Research Medical Rehabilitation Research • Challenge Grants, due April 27, 2009 – – – Behavioral interventions Clinical research Comparative effectiveness research Health disparities Etc. • Supplements to existing NIH grants, various dates

Most Common NIH Grant Types • Small Grants Program (R 03) – 2 years – Up to $50, 000 per year – 10 page proposal • Regular Research Awards (R 01) – Up to 5 years – Research costs not limited, but need permission to submit budget of over $500, 000 in direct costs in any year – 25 page proposal

Mentored Career Development Awards • Mentored Research Scientist Development Award (K 01) • Mentored Clinical Scientist Development Award (K 08) • Career Transition Award (K 22) • Mentored Patient-Oriented Research Career Development Award (K 23) • Mentored Quantitative Research Career Development Award (K 25)

Features of the Mentored Career Awards • Purpose: – Provide applicant with professional degree three-five years of additional supervised research – Training must be in an area new to the applicant and/or one in which additional supervised research experience will substantially add to the research capabilities of the applicant – Focus on progression to independence: The candidate must provide a plan for achieving independent research support by the end of the award period • Allowable Costs: – Annual Salary $48, 000 -90, 000 – Research Development Support up to $50, 000 per year

Review Criteria for Mentored Career Development Awards • Candidate: – Quality of the candidate's research, academic and/ or clinical record – Potential to develop as an independent researcher; and commitment to a research career • Career Development Plan: – The content, phasing, and duration of the plan – Consistency with the candidate's career goals – Likelihood the plan will contribute to achieving of scientific independence • Research Plan: – Methodology – Relevance to the candidate's career objectives – Appropriateness of the plan to the stage of research development – As a vehicle for developing research skills for career development

Review Criteria for Mentored Career Development Awards • Mentor/Co-Mentor: – Research qualifications – Quality and extent of mentor(s) role in providing guidance – Previous experience in fostering the development of researchers – History of research productivity – Adequacy of support for the proposed research project • Environment and Institutional Commitment: – Adequacy of research facilities and training opportunities – Quality of the environment for scientific and professional development – Institution's commitment to candidate—assurances that the institution intends the candidate to be an integral part of its research program – Institution's commitment to an appropriate balance of research and other responsibilities including 75% effort proposed by the candidate

Career Development Plan Pre-Doctoral Fellowship-F 31 Institutional Pre-Doctoral Fellowship-T 32 Post-Doctoral Fellowship-F 32 Institutional Post-Doctoral Fellowship-T 32 Do I need more training or changing career emphasis? Yes No Apply for Mentored K Do I have pilot data? Yes R 01 No Apply for R 03/ B/START

Applications for NIH Research Grants are normally submitted to NIH in three ways: • • • Unsolicited Grant Application Program Announcement (PA) - Institute or Center is inviting grant applications in a general scientific area of research. There are generally no funds set aside for these projects. A Request for Applications (RFA) - one or more NIH Institutes and Centers invite applications in a welldefined scientific research area. Specific funds are set aside for the projects.

NIH Guide for Grants and Contracts How do I find out about NIH PAs and RFAs? The NIH Guide Announces NIH Scientific Initiatives provides NIH Policy and Administrative Information. See: http: //www. nih. gov/grants/guide/index. html

Dual Review System for NIH Grant Applications Scientific Review Group (SRG) • Provides Initial Scientific Merit Review of Grant Applications • Rates Applications and makes Recommendations for Appropriate Level of Support and Duration of Award Second Level of Review: Institute or Center Council • Assesses Quality of SRG Review of Grant Applications • Makes Recommendation to Institute Staff on Funding • Evaluates Program Priorities and Relevance • Advises on Policy

NIH Peer Review Process The reviewers study each application individually before the meeting; and for each application, some reviewers are assigned to prepare written critiques. Those projects deemed most competitive, approximately the upper third, are fully discussed and given a priority score based on the scientific merits of the project.

Review Criteria • SIGNIFICANCE • APPROACH • INNOVATION • INVESTIGATOR • ENVIRONMENT

Review Process for A Grant Application Submitted to CSR, NIH National Institutes of Health Research Grant Application Initiates Research Idea School or Other Research Center for Scientific Review Assigns to IRG/Study Section & IC Study Section Submits Application Evaluates for Scientific Merit Institute Evaluates for Program Relevance Advisory Councils and Boards Conducts Research Allocates Funds Recommends Action Institute Director Takes final action for NIH Director

Normal Timeframe from Submission to Award for 398 Unsolicited Grants (PAs & RFAs may be different) There are normally three overlapping cycles per year : JAN FEB MAR APR MAY JUN JUL AUG SEP OCT NOV DEC JAN FEB MAR APR MAY JUN Cycle 1 Receipt Referral Review Council Award Cycle 2 Receipt Referral Review Council Award Cycle 3 Receipt Referral Review Council Award JUL

NIH’s Electronic Submission 1. Require electronic submission through Grants. gov for all NIH grant applications. 2. Transition from the PHS 398 application form to SF 424 family of forms data set.

Grant Writing Tips • First Steps: – Broaden your vision – Seek mentoring and research experience – Discuss your ideas with successful senior investigators – Institutional support for pilot projects? • Start early. Do not rush!

A Good Idea + Science 2 + Marketing = Art x (pilot data + good idea) Grantsmanship Your end product must: be clearly written and well structured be important be unique contribute significantly to the field!

Review Criteria • SIGNIFICANCE: address important problem? Will scientific knowledge be advanced? • APPROACH: design and methods appropriate to research questions? Are potential problem areas addressed? • INNOVATION: is the project original and innovative? • INVESTIGATOR: are investigators appropriately trained and well suited to carry out this work? Does the team bring complementary and integrated experience to the project? • ENVIRONMENT: does the scientific environment contribute to the probability of success? Is there evidence of institutional support?

Proposal Sections • • • Abstract Specific Aims Background and Significance Preliminary Studies Research Design and Methods

Abstract • Summarize: – Nature of the problem – Long-term objectives – Need for research – Specific aims – Research design and methods • Must grab the reviewers interest immediately

Specific Aims • Clear statement of the problem or question • Background material to provide context • Why proposal is innovative, needs to be done • Public health significance • What you plan to do (basics of design and outcomes) • Specific aims or hypotheses

Background and Significance • Problem study will address • Why a public health concern • What others have done and why that wasn’t sufficient • What you plan to do is different • How your research will have an impact on PH • Why your plan is novel • Overview of methods and hypotheses

Preliminary Studies • Description of the team, including prior collaborations and relevant experience • Studies conducted by the PI and key personnel that are relevant • Pilot data

Research Design and Methods • Overview of methods • Hypotheses • Study design, including strengths and advantages, and a discussion of possible alternatives and reasons for not choosing them • Subjects (population characteristics, inclusion/exclusion criteria) • Informed consent procedures • Recruitment and attrition information, including a flow chart

Research Design and Methods continued • Sample size and power calculations • Description of intervention, independent variables, and control variables • Description of outcomes • Procedures, including quality control • Randomization method • Study timeline • Data management and missing values • Statistical analyses • Dissemination of results • Potential limitations and solutions

For More Information NIH website: www. nih. gov NIH Office of Extramural Research: http: //grants 1. nih. gov/ grants/oer. htm

Grant Writing Tips Summary • Seek mentoring and research experience • Discuss your ideas with colleagues • Know NIH and its priorities • Discuss your ideas with NIH Program Staff • Write clearly and concisely with excellent organization. Strictly follow guidelines. • Avoid unnecessary complexity • Have senior colleagues critically read your application • Be open to helpful criticism • Be persistent!

Grant Writing Course • GMS 6811: Granting Writing Skills in Epidemiology and Clinical Research Instructor: Dr. Shenkman Fall Semester Wednesdays, 3 -6 PM 1329 Building

Elizabeth A. Shenkman, Ph. D, Director Kelli A. Komro, MPH, Ph. D, Associate Director Jill Boylston Herndon, Ph. D Damon Clark, Ph. D I-Chan Huang, Ph. D Caprice Knapp, Ph. D Mildred M. Maldonado-Molina, Ph. D June Nogle, Ph. D John Reiss, Ph. D Joseph V. Terza, Ph. D Alexander C. Wagenaar, Ph. D

Public Health Policies to he al th Qu ca al lif re ity e & o qu f h al eal ity th of Pa lli at iv e ca re Ac ca ce re ss Na co tio an mm na l d pr un , sta ac ity te tic po a es lic nd ie Co s an m d mu sc n ho ity ol or s g s Fa m ili es Continuum of Policy Research Health Care Policies

UF Research Mentors • CRISP: http: //crisp. cit. nih. gov/ • ICHP: www. ichp. ufl. edu